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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CV AXIUS CORONARY SHUNT CLAMP, VASCULAR

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MAQUET CV AXIUS CORONARY SHUNT CLAMP, VASCULAR Back to Search Results
Catalog Number C-OF-1500
Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017); Cut In Material (2454)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/27/2018
Event Type  Injury  
Manufacturer Narrative
Internal complaint number trackwise # (b)(4). The device has not yet been returned to maquet cardiac surgery for evaluation. We are following up with the customer for the return of the device. A supplemental report will be submitted if the device is received.
 
Event Description
The hospital reported that during a coronary artery bypass procedure, axius coronary shunt piece broke off into the patient. The surgeon had the shunt in the artery and snagged it with a stitch. He pulled the shunt out of the artery and tried to cut the stitch out instead he cut the shunt in half. Half of the shunt fell into the open pleural field and was unable to located. They used another shunt and finished the procedure. Patient had a normal hospital course following and was discharged home in normal time without any related complications.
 
Manufacturer Narrative
Internal complaint number: (b)(4). The remaining piece of the device was returned to the factory for evaluation. A visual inspection was conducted. Signs of clinical use with evidence of blood on most parts of the remaining piece of the device were observed. It was observed that the shunt was cut in half. The other half of the shunt was not returned. Microscopic inspection showed a portion of the coil remained inside the lumen of the shunt. The broken shunt was detached from the thread connecting the tab. The tab was labeled with maquet 1. 5. The replacement device used to complete the procedure was also returned; appeared intact and showed signs of clinical use and evidence of blood. The tab of the replacement device was labeled maquet 2. 0. Based on the returned condition of the device and the information provided, the reported failure mode "break" was confirmed. A lot history record review was completed for lot number 25130550, which is the only lot number shipped to the account prior to the event date. There was no nonconformance which could be considered related to the reported event recorded in the lot history.
 
Manufacturer Narrative
(b)(4).
 
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Brand NameAXIUS CORONARY SHUNT
Type of DeviceCLAMP, VASCULAR
Manufacturer (Section D)
MAQUET CV
45 barbour pond drive
wayne NJ 07470
Manufacturer (Section G)
MAQUET CV
45 barbour pond drive
wayne NJ 07470
Manufacturer Contact
45 barbour pond drive
wayne, NJ 07470
MDR Report Key7363989
MDR Text Key103269237
Report Number2242352-2018-00258
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K010117
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/22/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberC-OF-1500
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/07/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Device Age YR
Event Location No Information
Date Manufacturer Received05/07/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 03/22/2018 Patient Sequence Number: 1
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